Actively Recruiting

Age: 40Years - 74Years
All Genders
Healthy Volunteers
NCT06741293

Improving Colorectal Cancer Early Screening in Portugal: Identification of Gut Microbiome Biomarkers in Stool (GUTBIOME-PT)

Led by Gulbenkian Institute for Molecular Medicine · Updated on 2026-05-14

30000

Participants Needed

1

Research Sites

313 weeks

Total Duration

On this page

Sponsors

G

Gulbenkian Institute for Molecular Medicine

Lead Sponsor

H

Hospital CUF Descobertas, Lisbon, Portugal

Collaborating Sponsor

AI-Summary

What this Trial Is About

Colorectal cancer (CRC) is a major public health problem, responsible for 2 million new cases and almost 1 million deaths annually worldwide. In Portugal, as of 2022, CRC is the most common cancer, with 10,575 new cases reported, and the second leading cause of cancer-related mortality, accounting for 4,809 deaths (approximately 14% of all cancer-related deaths). In recent years, there has been an alarming increase in the incidence and mortality of CRC in people \<50 years of age. Early detection is crucial, as survival rates decline sharply from 90% when detected early to just 10% in advanced stages. Non-invasive diagnostic tests, such as the Faecal Immunochemical Test (FIT), have a low sensitivity for early-stage lesions and a high rate of false positives. Therefore, there is an urgent need to improve non-invasive diagnostic methods for the early detection of CRC, as effective screening can prevent it by detecting and removing premalignant lesions. Recent studies suggest that an altered gut microbiota may confer susceptibility to certain types of cancer. Interestingly, the gut microbiota of patients with adenomas or CRC differs from that of healthy individuals. This study aims to identify gut microbiome biomarkers in faecal samples associated with CRC and/or high-risk adenomas to improve early detection.

CONDITIONS

Official Title

Improving Colorectal Cancer Early Screening in Portugal: Identification of Gut Microbiome Biomarkers in Stool (GUTBIOME-PT)

Who Can Participate

Age: 40Years - 74Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to provide written informed consent and comply with study procedures
  • Reside in the Lisbon Metropolitan Area, Portugal
  • Age from 40 to 74 years
Not Eligible

You will not qualify if you...

  • Age under 40 years or 75 years and older
  • Unable to provide informed consent
  • Refusal to provide stool samples
  • Active oncological disease
  • Personal history of colorectal cancer
  • Personal history of colon adenomas removed in the last 24 months
  • First-degree family history of colorectal cancer
  • Previous diagnosis of inflammatory bowel disease (ulcerative colitis, Crohn's disease or indeterminate colitis), inflammatory bowel syndrome, persistent and infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhoea of unknown cause or recurrent infection by Clostridioides difficile
  • Severe cardiovascular or heart diseases with medical diagnosis
  • Severe renal failure requiring hemodialysis
  • Severe lung disease
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Gulbenkian Institute for Molecular Medicine

Lisbon, Lisbon District, Portugal, 1649-028

Actively Recruiting

Loading map...

Research Team

A

Ana S Almeida, PhD

CONTACT

M

Madalena Reis

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here